Holder, Heart-Valve, Prosthesis
Handle 7615XL Annuloplasty XL 26L CE
1manufacturer
10catalogue numbers in this listing
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hangtian Kadi Technology R&D Institute | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DTJ |
| Device type | Holder, Heart-Valve, Prosthesis |
| Device class | Class 1 |
| Regulation | 21 CFR 870.3935 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-07-19 |
| Record revised | 2024-12-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Length 216 to 373 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7639 | Length 234.0 mm | In distribution |
| 7639XL | Length 368.0 mm | In distribution |
| 7639 | Length 234.0 mm | In distribution |
| 7686 | Length 216.0 mm | In distribution |
| 7686 | Length 216.0 mm | In distribution |
| 7686XL | Length 373.0 mm | In distribution |
| 7686XL | Length 373.0 mm | In distribution |
| 7615XL | Length 373.0 mm | In distribution |
| 7639XL | Length 368.0 mm | In distribution |
| 7615 | Length 216.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Annuloplasty Handle | Medtronic, Inc. | 8 |
| Valve Handle | Medtronic, Inc. | 4 |
| Masters Series™ | St. Jude Medical | 3 |
| Profile 3D™ | Medtronic, Inc. | 3 |
| SJM™ | St. Jude Medical | 3 |
| Open Pivot™ | Medtronic, Inc. | 2 |
| Heart Valve Accessor | Edwards Lifesciences Technology Sarl | 2 |
| Avalus™ | Medtronic, Inc. | 2 |
| Mitris Handle 1140M | Edwards Lifesciences Technology Sarl | 1 |
| Flexible Handle | Edwards Lifesciences Technology Sarl | 1 |
| A Handle Compatible With Ring Holders Models 5100, 4900, 4100, 4200, 4450 AND 46 | Edwards Lifesciences Technology Sarl | 1 |
| Valve Handle 7420 | Medtronic, Inc. | 1 |
Showing 12 of 18. All products under Holder, Heart-Valve, Prosthesis
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.